CN1628874A - Guide wire - Google Patents

Guide wire Download PDF

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Publication number
CN1628874A
CN1628874A CNA2004100903851A CN200410090385A CN1628874A CN 1628874 A CN1628874 A CN 1628874A CN A2004100903851 A CNA2004100903851 A CN A2004100903851A CN 200410090385 A CN200410090385 A CN 200410090385A CN 1628874 A CN1628874 A CN 1628874A
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China
Prior art keywords
core
leading line
junction surface
mentioned
core body
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Granted
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CNA2004100903851A
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Chinese (zh)
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CN100558423C (en
Inventor
三岛克朗
伊藤丰
村山启
佐藤英雄
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Terumo Corp
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Terumo Corp
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Priority claimed from JP2003421659A external-priority patent/JP4376048B2/en
Priority claimed from JP2004011185A external-priority patent/JP4376073B2/en
Priority claimed from JP2004024573A external-priority patent/JP4376078B2/en
Application filed by Terumo Corp filed Critical Terumo Corp
Publication of CN1628874A publication Critical patent/CN1628874A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09058Basic structures of guide wires
    • A61M2025/09083Basic structures of guide wires having a coil around a core
    • A61M2025/09091Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09133Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/0915Guide wires having features for changing the stiffness

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Inorganic Fibers (AREA)
  • Investigating Strength Of Materials By Application Of Mechanical Stress (AREA)

Abstract

A guide wire (1) has a wire body (10) having a first wire (2) disposed at a distal end thereof and a second wire (3) joined to a proximal end of the first wire. The first wire (2) and the second wire (3) are preferably joined to each other by welding, providing a layer joint (14) therebetween. The joint (14) is of a curved shape, particularly, a convex curved shape that is convex toward the proximal end of the wire body (10). In the joint (14), at least one component (e.g., Ti) of the material of the first wire (2) decreases toward the proximal end, and at least one component (e.g., Fe) of the material of the second wire (3) decreases toward the distal end. When a tensile test is conducted on a region of the wire body (10) including the joint (14), the region of the wire body (10) has, in a tensile load and elongation diagram, an elastic section extending substantially straight upwardly to the right, a yield section extending substantially horizontally or upwardly to the right from the elastic section, and a substantially straight section extending upwardly to the right from the yield section. The region of the wire body (10) has such characteristics that the region is fracturable near a terminal end of the straight section at a fracture position on other than the joint (14).

Description

Leading line
Technical field
The present invention relates to a kind of leading line (guide wire), the leading line that uses when particularly conduit being introduced in the body cavity such as blood vessel.
Background technology
Percutaneous coronary endoluminal vascular plasty) and so on leading line is used for introducing (the Percutaneous Transluminal CoronaryAngioplasty: be difficult to carry out the treatment at operating position or check the conduit that uses to reduce treatment that invasion and attack to human body are purpose or angiocardiography etc. of PTCA for example.The leading line that uses among the PTCA makes under the leading line front end state more outstanding than foley's tube front end, together is inserted near the angiostenosis portion as target site with foley's tube, and the leading section of foley's tube is introduced near the angiostenosis portion.
Because the vascular bending complexity, the leading line that uses when requiring that therefore foley's tube inserted blood vessel has embedability and transmission of torque (being generically and collectively referred to as " operability ") and the anti-kinking (folding song) etc. that are passed to front to the crooked flexibility of appropriateness and nerve, for the operation that makes base end part.Structure as the appropriate flexibility that is used for obtaining above-mentioned characteristic, have in revolution place of the very thin front end core of leading line the wire coil that bending is had flexibility is installed, or use the core of super-elastic wire such as Ni-Ti as the leading line that is used to give flexibility and nerve.
The core of existing leading line is made of a kind of material in fact, in order to improve the operability of leading line, adopts the higher material of elastic modelling quantity, and its influence is for there being the tendency of the flexibility of losing the leading line leading section.In addition, if use the lower material of elastic modelling quantity, then lose the operability of leading line base end side for the flexibility that obtains the leading line leading section.Therefore, only use a kind of core, be difficult to satisfy essential flexibility and operability.
In order to improve above-mentioned defective, for example, a kind of leading line is disclosed in USP5171383, its core uses the Ni-Ti alloy wire, under different conditions its front and base end side is implemented heat treatment, improves the flexibility of leading section, and improves the rigidity of base end side.
But utilizing above-mentioned heat treatment is limited to the control of flexibility, even leading section can access enough flexibilities, base end side also may not satisfy the rigidity requirement.
In addition, a kind of leading line is disclosed among the USP6001068, by the 1st core (wire) that is configured in front with flexible, be configured in the 2nd high core of the rigidity of base end side and connect the 1st core and the tubular connecting element with ditch and slit of the 2nd core constitutes, link is constituted rigidity increases gradually to base end side from front.
Above-mentioned leading line can dispose the core with desired characteristic respectively in front and base end side, but, because two cores connect via piped link, therefore can't improve the bond strength of two cores, existence can't obtain the problem of sufficient transmission of torque.In addition, the problem that also has more loaded down with trivial details and so on the manufacture view of the attended operation of core.
Summary of the invention
Purpose of the present invention for provide a kind of when fully guaranteeing flexibility and operability the high leading line of bond strength of the 1st core and the 2nd core.
Purpose of the present invention realizes by a kind of leading line, described leading line has the core body, this core body has the 1st core of the front of being configured in, the 2nd core that constitutes greater than the material of above-mentioned the 1st core constituent material with the cardinal extremity that is bonded on above-mentioned the 1st core, by elastic modelling quantity, it is characterized by, the junction surface of above-mentioned the 1st core and above-mentioned the 2nd core forms the curved surface shape, and is with respect to the roughly symmetric shape of the central shaft of above-mentioned core body.
Above-mentioned junction surface is preferably formed the convex-shaped to the proximal direction projection of above-mentioned core body.The preferred welding method that adopts engages above-mentioned the 1st core with above-mentioned the 2nd core.Above-mentioned junction surface is preferably formed stratiform.The lamellated junction surface of above-mentioned formation thickness is preferably 0.001~100 μ m.The external diameter of above-mentioned core body at above-mentioned junction surface is preferably greater than the external diameter at the base end side position at above-mentioned junction surface.The external diameter of above-mentioned core body at above-mentioned junction surface is preferably greater than the base end side at above-mentioned junction surface and the external diameter at front position.The periphery of above-mentioned core body preferably has the coating of being arranged to cover at least above-mentioned junction surface.Above-mentioned coating preferably is made of the material that can reduce friction.Above-mentioned coating preferably is made of thermoplastic elastomer (TPE), organic siliconresin or fluorine resin.The average thickness of above-mentioned coating is preferably 1~30 μ m.Above-mentioned core body preferably has decrescence portion of extreme direction reduces gradually before the outer radial external diameter.The spiral coil that preferably has the part of front at least of above-mentioned the 1st core of lining.Preferably comprise common metallic element in above-mentioned the 1st core and above-mentioned the 2nd core constituent material separately.Above-mentioned the 1st core preferably is made of superelastic alloy.Above-mentioned the 2nd core preferably is made of rustless steel or Co base alloy.Above-mentioned Co base alloy is preferably Co-Ni-Cr class alloy.
In addition, above-mentioned purpose can realize by a kind of leading line, described leading line has the core body, this core body has the 1st core that is configured in front that engages via the junction surface, with the base end side that is configured in above-mentioned the 1st core, by the 2nd core that the material different with above-mentioned the 1st core constitutes, it is characterized by, at above-mentioned junction surface, the 1st composition in above-mentioned the 1st core constituent material reduces to proximal direction, and the 2nd composition forward end direction in above-mentioned the 2nd core constituent material reduces.
Above-mentioned the 2nd core preferably is made of the material of elastic modelling quantity greater than above-mentioned the 1st core constituent material.Preferably comprise common metallic element in above-mentioned the 1st core and above-mentioned the 2nd core constituent material separately.Above-mentioned the 1st core preferably is made of Ni-Ti class alloy.Above-mentioned the 2nd core preferably is made of rustless steel or Co base alloy.Above-mentioned Co base alloy is preferably Co-Ni-Cr class alloy.Above-mentioned junction surface is preferably formed the curved surface shape.Above-mentioned junction surface is preferably formed with respect to the symmetric shape of above-mentioned core body central shaft.Above-mentioned junction surface is preferably formed the convex-shaped to the proximal direction projection of above-mentioned core body.The preferred welding method that adopts engages above-mentioned the 1st core with above-mentioned the 2nd core.The lamellated junction surface of above-mentioned formation thickness is preferably 0.001~100 μ m.The external diameter of above-mentioned core body at above-mentioned junction surface is preferably greater than the base end side at above-mentioned junction surface and the external diameter at front position.The periphery of above-mentioned core body preferably has the coating at the above-mentioned junction surface of being arranged to be covered at least.Above-mentioned coating preferably is made of the material that can reduce friction.Above-mentioned coating preferably is made of thermoplastic elastomer (TPE), organic siliconresin or fluorine resin.The average thickness of above-mentioned coating is preferably 1~30 μ m.Above-mentioned core body preferably has decrescence portion of extreme direction reduces gradually before the outer radial external diameter.The spiral coil that preferably has the part of front at least of above-mentioned the 1st core of lining.At above-mentioned junction surface, above-mentioned the 1st composition and/or above-mentioned the 2nd composition preferably have a plurality of different Concentraton gradient at the long axis direction of core body.Above-mentioned a plurality of Concentraton gradient preferably includes more demulcent the 1st Concentraton gradient and the 2nd Concentraton gradient and steeper the 3rd Concentraton gradient between the two.
Above-mentioned purpose realizes by a kind of leading line, described leading line has the core body, this core body has the front of being configured in, the 1st core that constitutes by the material that shows pseudoelasticity and through the cardinal extremity of solder joints at above-mentioned the 1st core, the 2nd core that constitutes greater than the material of above-mentioned the 1st core constituent material by elastic modelling quantity, it is characterized by, in the tensile load-extensograph at the position that comprises the junction surface of above-mentioned core body, have to upper right side roughly Hookean region and the approximate horizontal that links to each other with this Hookean region of linearly extension or the yield range that extends to the upper right side, have in the characteristic that fracture takes place under higher load from above-mentioned yield range terminal, and this fracture position is the position beyond the above-mentioned junction surface.
And, above-mentioned purpose realizes by a kind of leading line, described leading line has the core body, this core body has the front of being configured in, the 1st core that constitutes by the material that shows pseudoelasticity and through the cardinal extremity of solder joints at above-mentioned the 1st core, the 2nd core that constitutes greater than the material of above-mentioned the 1st core constituent material by elastic modelling quantity, it is characterized by, when tension test is carried out at the position that comprises the junction surface of above-mentioned core body, in tensile load-extensograph, have to the upper right side Hookean region of linearly extension roughly, approximate horizontal that links to each other with this Hookean region or the yield range that extends to the upper right side, with link to each other with this yield range to the linearity region of linearly extension roughly, upper right side, has the characteristic that fracture takes place near the terminal of above-mentioned linearity region, and the fracture strength at above-mentioned junction surface is greater than the leading section of above-mentioned the 2nd core.
Above-mentioned purpose realizes by a kind of leading line, described leading line has the core body, the 1st core that this core body has the front of being configured in, be made of the material that shows pseudoelasticity, the 2nd core that constitutes greater than the material of above-mentioned the 1st core constituent material by elastic modelling quantity and the cardinal extremity of above-mentioned the 1st core is engaged the junction surface that forms with the front end of above-mentioned the 2nd core through welding, it is characterized by, the fracture strength at above-mentioned junction surface is also greater than the leading section of above-mentioned the 2nd core.
In above-mentioned tensile load-extensograph, the crooked downwards phenomenon of tensile load-extension curve that is caused by the necking down effect preferably appears when closing on fracture.The fracture strength of above-mentioned core body is preferably 4kg weight or more than the 4kg weight.Above-mentioned the 1st core preferably is made of superelastic alloy.Above-mentioned the 2nd core preferably is made of rustless steel or Co base alloy.The junction surface of above-mentioned the 1st core and above-mentioned the 2nd core is preferably formed the curved surface shape, and is with respect to the symmetric shape of the central shaft of above-mentioned core body.Above-mentioned junction surface is preferably formed the convex-shaped to the proximal direction projection of above-mentioned core body.Above-mentioned junction surface is preferably formed layer structure.The thickness at the junction surface of above-mentioned formation layer structure is preferably 0.001~100 μ m.Above-mentioned coating preferably is made of the material that can reduce friction.Above-mentioned coating preferably is made of thermoplastic elastomer (TPE), silicones or fluorine resin.The average thickness of above-mentioned coating is preferably 1~30 μ m.Above-mentioned core body preferably has decrescence portion of extreme direction reduces gradually before the outer radial external diameter.The spiral coil that preferably has the part of front at least of above-mentioned the 1st core of lining.Preferably comprise common metallic element in above-mentioned the 1st core and above-mentioned the 2nd core constituent material separately.
According to the present invention, can provide the high leading line of bond strength of a kind of the 1st core and the 2nd core.Engage use by the 1st core that physical characteristic is different and the 2nd core, can fully guarantee flexibility and operability, even under the situation that leading line is imposed bending or stretching iso-stress, the junction surface of the 1st core and the 2nd core does not break away from yet, in addition, can be positively from the distolateral forward transmission torsional moment of base end side or be pressed into power.
Description of drawings
Fig. 1 is the profilograph of expression leading line embodiment of the present invention.
Fig. 2 will amplify the profilograph that shows near the junction surface of core body in the leading line of the present invention.
Fig. 3 carries out the result's of composition analysis curve chart to the vertical section of core body in the leading line of the present invention with the Auger electron spectrum analysis for expression.
Fig. 4 is the tensile load-extensograph (ideograph) when the core body is carried out tension test.
Fig. 5 is the tensile load-extensograph (ideograph) when the core body is carried out tension test.
Fig. 6 is the tensile load-extensograph when the core body is carried out tension test.
Fig. 7 is the ideograph that makes use-case that is used to illustrate leading line of the present invention.
Fig. 8 is the ideograph that makes use-case that is used to illustrate leading line of the present invention.
Drawing reference numeral
1 leading line
10 core bodies
2 the 1st cores
3 the 2nd cores
4 coils
5 coatings
11,12,13 immobilization materials
14 junction surfaces (weld part)
15 external diameters are portion decrescence
16 external diameters are portion decrescence
17 protuberances
18 external diameters are portion decrescence
20 foley's tubes
201 sacculus
30 guiding catheters
40 large artery trunks bow
50 right coronary arteryes
60 right coronary artery peristomes
70 angiostenosis portions
The specific embodiment
Below, based on preferred embodiment shown in the drawings, describe leading line of the present invention in detail.
Fig. 1 is the profilograph of expression leading line embodiment of the present invention, and Fig. 2 will amplify the profilograph that shows near the junction surface of core body in the leading line of the present invention.Need to prove that for convenience of explanation the right side among Fig. 1 and Fig. 2 is called " cardinal extremity ", and the left side is called " front end ".In addition, in Fig. 1, for the ease of watching, with the length direction of leading line shorten, the width of leading line is exaggerative, pattern this leading line is shown, length direction is different with the ratio and the actual size of width.
Leading line 1 shown in Figure 1 is to insert the conduit leading line that uses in the conduit, this leading line has core body 10 and spiral coil 4, and core body 10 is formed by the 2nd core 3 joints (connection) of the 1st core 2 that is configured in front and the base end side that is configured in the 1st core 2.The length overall of leading line 1 is not particularly limited, and is preferably about 200~5000mm.In addition, the external diameter of leading line body 10 (external diameter of external diameter standing part) is not particularly limited, and is preferably about 0.2~1.4mm usually.
The 1st core 2 is made of the rubber-like wire rod.The length of the 1st core 2 is not particularly limited, and is preferably about 20~1000mm.
In the present embodiment, the 1st core 2 has the part (external diameter is portion decrescence) that extreme direction reduces gradually before the fixed part of external diameter and the outer radial.The latter can have a place, two places also can be arranged or more than two places, in illustrated embodiment, decrescence portion 15,16 of two place's external diameters is arranged.
By having decrescence portion 15,16 of this external diameter, rigidity (flexural rigidity, torsional rigid) the forward end direction of the 1st core 2 is reduced gradually, its result obtains good flexibility for the leading section at leading line 1, raising also can prevent generations such as bending simultaneously to tracing property, the safety of blood vessel.
In diagram constituted, external diameter decrescence portion 15,16 was respectively formed at the part of the 1st core 2 long axis directions, also can constitute decrescence portion of external diameters with the 1st core 2 is whole.In addition, the external diameter decrescence tapering of portion 15,16 (external diameter slip) can be a certain value along the core long axis direction, also can have the position that changes along long axis direction.For example, also can form tapering (external diameter slip) bigger position and less position and alternately repeatedly repeat the structure that forms.
In addition, also can with diagram constitute form differently external diameter decrescence the cardinal extremity of portion 16 be positioned at the structure in the centre position of the 2nd core 3, that is, make decrescence portion 16 structure of crossing over the junction surface (weld part) 14 of the 1st cores 2 and the 2nd core 3 of external diameter.
The constituent material of the 1st core 2 is not particularly limited, and for example, can use various metal materials such as rustless steel, wherein, especially preferably shows the alloy (comprising superelastic alloy) of pseudoelasticity.More preferably superelastic alloy.Because superelastic alloy is soft, has nerve simultaneously, be difficult for producing bending defect, therefore by constitute the 1st core 2 with superelastic alloy, can partly obtain sufficient flexibility in the front of leading line 1 and to the nerve of bending, thereby improved tracing property, obtained better operability the flexural buckling blood vessel of complexity.Simultaneously, even the 1st core 2 repeats the bending deformation that bends, under the effect of the nerve that the 1st core 2 has, also be difficult to produce bending defect, therefore can be in the use of leading line 1, prevent that the operability that the bending defect by the 1st core 2 causes from reducing.
The arbitrary shape that comprises the stress-deformation curve that produces because of stretching in the pseudoelasticity alloy, comprise the material that critical points such as As, Af, Ms, Mf can significantly be measured, also comprise the material that significantly to measure, comprise by stress causing distortion (distortion) significantly, being whole alloys of original shapes except that roughly replying after the destressing.
Preferred composition as superelastic alloy, can enumerate the Ni-Ti class alloys such as Ni-Ti alloy of 49~52 atom %Ni, 38.5 the Cu-Zn alloy of~41.5 weight %Zn, Ni-Al alloy of the Cu-Zn-X alloy of 1~10 weight %X (X be among Be, Si, Sn, Al, the Ga at least a), 36~38 atom %Al etc.Wherein, preferred especially above-mentioned Ni-Ti class alloy.Need to prove that the superelastic alloy of Ni-Ti class alloy representative and the adaptation of following coating 5 also are good.
The front end of the 2nd core 3 is for example through being welded to connect (binding) cardinal extremity at the 1st core 2.The 2nd core 3 is made of the rubber-like wire rod.The length of the 2nd core 3 is not particularly limited, and is preferably about 20~4800mm.
The 2nd core 3 preferably is different from the material formation of the 1st core 2 usually by elastic modelling quantity (Young's modulus (vertical coefficient of elasticity), modulus of rigidity (transverse elasticity coefficient), bulk modulus), especially preferably be made of the material of elastic modelling quantity greater than the 1st core 2.Thus, can make the 2nd core 3 have the rigidity (flexural rigidity, torsional rigid) of appropriateness, make leading line 1 become the strong material of so-called rigidity, improve embedability and transmission of torque, obtain better insertion operability.
The constituent material of the 2nd core 3 (wire rod) is not particularly limited, and can use various metal materials such as rustless steel (for example whole kinds of SUS such as SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302), piano wire, cobalt alloy, pseudoelasticity alloy.
Wherein, the elastic modelling quantity height of cobalt alloy when making core, and have appropriate elastic limit.Therefore, the 2nd core 3 that is made of cobalt alloy has good especially transmission of torque, problems such as extremely difficult generation flexing.As cobalt alloy, containing Co as long as constitute element, can use any alloy, preferably is alloy (the Co base alloy: constitute in the element of alloy of main constituent with Co, the containing ratio of Co is counted maximum alloys with weight ratio), more preferably use Co-Ni-Cr class alloy.Alloy by using this composition can make above-mentioned effect more remarkable as the constituent material of the 2nd core 3.In addition, even, also have plasticity, therefore, for example can wait in use easily to be deformed into desirable shape under the situation because the alloy of above-mentioned composition deforms at normal temperatures.In addition, the alloy coefficient of elasticity height of above-mentioned composition, even and be under the high resiliency limit and also can carry out cold roll forming, has the high resiliency limit, can fully prevent the generation of flexing thus, can reduce diameter simultaneously, have sufficient flexibility and rigidity and insert the regulation position.
As Co-Ni-Cr class alloy, for example, preferably contain the alloy of the composition of 28~50wt%Co-10~30wt%Ni-10~30wt%Cr-surplus Fe, or wherein a part by the alternate alloy of other elements (substitute element) etc.Contain substitute element and can bring into play the intrinsic effect of corresponding its kind.For example, by containing at least a substitute element of from Ti, Nb, Ta, Be, Mo, selecting, can realize further improving the effects such as intensity of the 2nd core 3.When need to prove the element that contains beyond Co, Ni, the Cr, its (substitute element is all) content is preferably 30wt% or below the 30wt%.
The part of Co, Ni, Cr also can be by other element substitutions.For example, the part of Ni also can be substituted by Mn.Thus, for example can realize the further improvement etc. of processability.The part of Cr also can be substituted by Mo and/or W.Can realize the further improvement of elastic limit etc. thus.In the Co-Ni-Cr class alloy, especially preferably contain the Co-Ni-Cr-Mo class alloy of Mo.
Concrete composition as Co-Ni-Cr class alloy, for example can enumerate (1) 40wt%Co-22wt%Ni-25wt%Cr-2wt%Mn-0.17wt%C-0.03wt%Be-surplus Fe, (2) 40wt%Co-15wt%Ni-20wt%Cr-2wt%Mn-7wt%Mo-0.15wt%C-0.03wt%Be-surplus Fe, (3) 42wt%Co-13wt%Ni-20wt%Cr-1.6wt%Mn-2wt%Mo-2.8wt%W-0.2wt%C-0.04wt%Be-surplus Fe, (4) 45wt%Co-21wt%Ni-18wt%Cr-1wt%Mn-4wt%Mo-1wt%Ti-0.02wt%C-0. 3wt%Be-surplus Fe, (5) 34wt%Co-21wt%Ni-14wt%Cr-0.5wt%Mn-6wt%Mo-2.5wt%Nb-0.5wt%T a-surplus Fe etc.Comprise above-mentioned alloy in the notion of the alleged Co-Ni-Cr class of the present invention alloy.
When using rustless steel, can make leading line 1 have better embedability and transmission of torque as the constituent material of the 2nd core 3.
The 1st core 2 and the 2nd core 3 are preferably different types of alloy, and in addition, the 1st core 2 preferably is made of the material of elastic modelling quantity less than the constituent material of the 2nd core 3.Thus, can make the front of leading line 1 partly have good flexibility, can make the part of base end side be rich in rigidity (flexural rigidity, torsional rigid) simultaneously.Its result makes leading line 1 obtain good embedability or transmission of torque, guarantees good operability, obtains good flexibility, nerve in front simultaneously, improves tracing property, safety to blood vessel.
As the concrete combination of the 1st core 2 and the 2nd core 3, preferred especially the 1st core 2 is made of superelastic alloy (particularly Ni-Ti class alloy), and the 2nd core 3 is made of Co base alloy (particularly Co-Ni-Cr class alloy) or rustless steel (Fe-Cr-Ni class alloy).Thus, can make above-mentioned effect become more remarkable.In addition, other reasons of preferred combinations thereof are for to contain common metallic element (for example Ni) in the 1st core 2 and the 2nd core 3 constituent material separately.When welding two cores as described below,, then can further improve the bond strength at junction surface 14 if contain common metallic element.Therefore, when being used for following tension test, can avoid junction surface 14 fracture, reliability when obtaining being used for organism, safe leading line 1.
The external diameter of the 2nd core 3 about equally, still, near near the external diameter that extreme direction reduced gradually before (base end side at junction surface 14) had outer radial the front end of the 2nd core 3 is portion 18 decrescence.Owing to there is decrescence portion 18 of this external diameter, therefore from the 2nd core 3 to the 1st core 2, physical characteristic, particularly elasticity change smoothly, good embedability or transmission of torque can be brought into play in 14 front and back at the junction surface, also can improve anti-kinking.As other examples at above-mentioned soft position, can enumerate and near the front end of the 2nd core 3, have the position that yield stress or elastic modelling quantity are lower than other parts.Thus, make the front end of the 2nd core 3 neighbouring, the 1st core 2 is constituted than more soft near the front end of the 2nd core 3 than near the part softness in addition of this front end.By increase flexibility interimly, can access good embedability or transmission of torque, anti-kinking.
Coil 4 is that wire rod (fine rule) is wound into the parts that helical form obtains, the front part of the 1st core 2 of being arranged to be covered.In diagram constituted, the front of the 1st core 2 was partly inserted the approximate centre portion of coil 4 inboards.In addition, the front of the 1st core 2 part is inserted in the mode that does not contact coil 4 inner surfacies.Joint boundary portion 14 is positioned at the position than the more close base end side of cardinal extremity of coil 4.
Need to prove in diagram constitutes, coil 4 is under the state that does not apply external force, be wound into spiral helicine wire rod and have a little space to each other, also can constitute different with diagram, coil 4 closely is configured under the state that does not apply external force, compactly is wound into spiral helicine wire rod and does not have the space to each other.
Coil 4 preferably is made of metal material.As the metal material that constitutes coil 4, for example can enumerate noble metal such as rustless steel, superelastic alloy, cobalt alloy or gold, platinum, tungsten or contain the alloy (for example platinum-indium alloy) etc. of above-mentioned metal.Particularly with noble metal etc. not the material of transmitted X-rays constitute under the situation of this coil, leading line 1 can access x-ray imaging, can the limit confirms the position of leading section under radioscopy, insert in the organism on the limit, is preferred therefore.The front of coil 4 also can form with different materials with base end side.For example, can for front use the coil, the base end side that form by the material of transmitted X-rays not use can transmitted X-rays by comparison the various formations such as coil that form of material (rustless steel etc.).The length overall of coil 4 is not particularly limited, and is preferably about 5~500mm.
The base end part of coil 4 and leading section are fixed on the 1st core 2 by immobilization material 11 and 12 respectively.The pars intermedia of coil 4 (near the position of front end) is fixed on the 1st core 2 by immobilization material 13.Immobilization material 11,12 and 13 is made of solder (scolding tin).Immobilization material 11,12 and 13 is not defined as scolding tin, can be binding agent yet.The fixing means of coil 4 is not defined as with immobilization material and fixes, and for example, can adopt welding method to fix yet.In order to prevent the blood vessel damage, preferably the front end face of immobilization material 12 is made circular shape.
In the present embodiment, by above-mentioned coil 4 is set,, reduce contact area with 4 linings of the 1st core 2 usefulness coils, therefore can reduce resistance to sliding, thereby further improve the operability of leading line 1.
Under the situation of the present embodiment, coil 4 uses the wire rod of cross section as circle, but is not limited thereto, and the section of wire rod for example also can be oval, square shapes such as (particularly rectangles).
The 1st core 2 that constitutes leading line body 10 is connected, fixes with the 2nd core 3 preferred welding methods that adopt.Thus, can use simple method, make the junction surface (weld part) 14 of the 1st core 2 and the 2nd core 3 have high bond strength, thereby, make leading line 1 torsional moment or the power that is pressed into that the 2nd core 3 produces positively can be passed to the 1st core 2.
As shown in Figure 2, this junction surface 14 for example can form stratiform." stratiform " is not limited to visual stratiform, also comprises forming notional stratiform, for example makes the ingredient significant change.Lamellated junction surface 14 is to extending with the direction of the intersect vertical axis of leading line body 10.Lamellated junction surface 14 preferred convex-shaped.The thickness of this layer is preferably about 0.001~100 μ m, more preferably about 0.1~15 μ m, more preferably about 0.3~2 μ m.In addition, this layer also can contain the thicker part in thickness part, preferably has roughly the same thickness.By junction surface 14 being formed the layer structure of this thickness, can access higher bond strength.
In Fig. 2, for easy to understand, the interface of the material of the material that forms lamellated junction surface 14 and the 1st core 2 or the 2nd core 3 is shown clearly, still, also can there be clear and definite boundary face between junction surface 14 and above-mentioned any material.
In the layer at the junction surface 14 that engages through welding, mix the composition (metallic element) in composition (metallic element) that exists in the metal material that constitutes the 1st core 2 and the metal material that constitutes the 2nd core 3.In other words, preferably along with the variation at position, make the 1st core 2, junction surface 14 and the 2nd core 3 separately constituent material composition little by little (continuously) change.Preferred version is at the junction surface 14, and at least one composition in the constituent material of the 1st core 2 is reduced to proximal direction (direction of the 2nd core 3), and at least one composition forward end direction (direction of the 1st core 2) in the constituent material of the 2nd core 3 reduces.
Below, enumerate concrete example and describe.Constitute the 1st core 2 with Ni-Ti class alloy, when constituting the 2nd core 3 with rustless steel (Fe-Cr-Ni class alloy), in junction surface 14, Fe and Cr have the tendency that reduces gradually from the 2nd core 3 side direction the 1st core 2 sides, and Ni and Ti have the tendency that reduces gradually from the 1st core 2 side direction the 2nd core 3 sides.
The vertical section central shaft of the core body that obtains along the 1st core 2 that adopts the welding of upset welding method to constitute by Ni 55.91wt%-surplus Ti and unavoidable impurities such as C, O and the 2nd core 3 that constitutes by unavoidable impurities (SUS302) such as Cr 18.19wt%-Ni 8.03wt%-surplus Fe and Mn, utilize the Auger electron spectrum analysis to carry out composition analysis, the curve chart of expression analysis result is shown in Fig. 3.
As shown in Figure 3, in the 1st core 2, certain substantially as the concentration of the Ni of the composition of the 1st core 2 and Ti, in junction surface 14, the concentration of Ni and Ti reduces to the direction of the 2nd core 3 respectively.In the 2nd core 3, the concentration of Ni is certain substantially, and the concentration of Ti is almost 0.In addition, in the 2nd core 3, certain substantially as the concentration of the Fe of the composition of the 2nd core 3 and Cr, in the 1st core 2, the concentration of Fe and Cr is almost 0 respectively.In junction surface 14, the concentration of Fe and Cr increases to the direction of the 2nd core 3 respectively.
In more detail, in Fig. 3, the Ni at 14 places, junction surface and the concentration of Ti reduce gradually in the direction of the 1st core 2 side direction the 2nd core 3, and some part reduces rapidly at boundary, and reduces gradually in the 2nd core 3 sides.That is, comprise junction surface 14 near the position, at least one composition in the material of the 1st core 2 reduces with at least 2 kinds of different Concentraton gradient to the direction of the 2nd core 3.The Ni at 14 places, junction surface and the concentration of Ti have the 1st Concentraton gradient that reduces gradually at the 1st core 2 side direction base end sides, the 2nd Concentraton gradient that reduces gradually at the 2nd core 3 side direction base end sides and the centre position that is positioned at the 1st and the 2nd Concentraton gradient, greater than the 3rd Concentraton gradient of the above-mentioned the 1st and the 2nd Concentraton gradient.In addition, the concentration of junction surface 14 Fe of place extreme direction before the 2nd core 3 side direction reduces gradually, and some part reduces rapidly at boundary, and reduces gradually in the 1st core 2 sides.That is, comprise junction surface 14 near the position, at least one composition in the material of the 2nd core 3 reduces with at least 2 kinds of different Concentraton gradient to the direction of the 1st core 2.The concentration of junction surface 14 Fe of place has the 1st Concentraton gradient that reduces gradually in the 2nd core 3 side direction front, the 2nd Concentraton gradient that reduces gradually in the 1st core 2 side direction front and the centre position that is positioned at the 1st and the 2nd Concentraton gradient, the 3rd steep Concentraton gradient of the more above-mentioned the 1st and the 2nd Concentraton gradient.
Can following consideration the above-mentioned the 1st and the 2nd Concentraton gradient and the 3rd Concentraton gradient.That is, utilizing welding to mix with Fe, Cr in the Ni in the 1st core, Ti and the 2nd core, Ni is the constituent of representative, usually, if mix Fe and Ti, then can form fragile intermetallic compound.In the present invention, because the mixing portion of Fe and Ti is considerably less,, also can not make it show fragility even therefore form intermetallic compound.This mixing portion is equivalent to above-mentioned the 3rd Concentraton gradient.And, can think that the 1st and the 2nd Concentraton gradient of its both sides is that compositions such as Fe or Ti reduce gradually or increase and form under diffusion.Therefore, can think with making the 1st and the 2nd Concentraton gradient partial continuous, can keep the seriality of atomic series, relax rapid rerum natura and change,, also can not show fragility even form intermetallic compound by being present in the both sides of the 3rd Concentraton gradient.By making 1st and 2nd Concentraton gradient mild partly be present in the both sides of the 3rd Concentraton gradient part than the 3rd Concentraton gradient, not only can keep hot strength, and to crooked or reverse also and can keep stronger bond strength.
Elemental analysis method is not limited to above-mentioned Auger electron spectrum analysis, for example, also can adopt any methods such as x-ray photoelectron spectrum analysis (XPS), electron probe microanalyzer (EPMA), x-ray fluorescence analysis.
By changing the composition (ingredient) at junction surface 14 and position, front and back thereof, can access higher bond strength.
The welding method of the 1st core 2 and the 2nd core 3 is not particularly limited, for example, can enumerate friction press welding, the spot welding of using laser, butt seam welding constant resistance butt welding method etc., consider preferred especially upset welding method from can obtain high bond strength aspect fairly simplely.When adopting the upset welding method to weld, material or external diameter that welding condition depends on the core of welding preferably weld under the following conditions.The plus-pressure of two cores is preferably 30~400kgf/mm 2If plus-pressure is lower than 30kgf/mm 2, it is bad then may to cause sparking; If be higher than 400kgf/mm 2, then may breaking plant.50~200kgf/mm more preferably 2The current value of switching between two cores is preferably 40~1000A.If current value is lower than 40A, then bond strength is low; If current value is higher than 1000A, then intensity significantly reduces.60~700A more preferably.Be preferably 5~100ms conduction time.If be less than 5ms conduction time, then can't reach desirable current value; If more than 100ms, then can't improve intensity.Be preferably 10~60ms.
The shape at junction surface 14 is not particularly limited, and also can preferably form the curved surface shape as shown in Figures 1 and 2 for plane.Be preferably formed convex-shaped especially to the proximal direction projection of core body 10.In addition, also can form convex-shaped to the preceding extreme direction projection of core body 10.The curved surface at junction surface 14 is preferably with respect to the roughly symmetric shape of the central shaft of core body 10.That is, preferably to constitute with the central shaft of core body 10 be the rotary body shape at center to the curved surface at junction surface 14.As the rotary body shape at junction surface 14, except plate-like, for example can enumerate dome shape, parabolic shape or be similar to the shape of above-mentioned shape.
Junction surface 14 is formed above-mentioned shape can obtain following effect.That is, because junction surface 14 is formed the curved surface shape, therefore compare with the plane, it is big that bonding area becomes, and disperseed the stress to bending simultaneously, thereby can access higher bond strength.In addition, because the curved surface at junction surface 14 is with respect to the symmetric shape of the central shaft of core body 10, therefore when reversing core body 10, torque (can not be departed from ground) equably and be passed to the 1st core 2 from the 2nd core 3.Thus, help to improve operability.
The external diameter at core body 10 14 places at the junction surface is greater than the external diameter at 14 base end side positions, junction surface.More preferably as shown in Figure 2, make the external diameter of the external diameter at core body 10 14 places greater than junction surface 14 base end sides and front position at the junction surface.The specific region that comprises junction surface 14 in the core body 10 has the protuberance 17 that forms some outstanding (protuberances) to peripheral direction.By forming above-mentioned formation, can further increase the bonding area at junction surface 14, thereby improve bond strength, the torsional moment or the power that is pressed into that the 2nd core 3 is produced more positively are passed to the 1st core 2.
In addition, by having protuberance 17, for example, can under radioscopy, more easily discern the position at 14 places, junction surface.Its result can simply and exactly grasp leading line 1 or conduit wait the position in blood vessel the situation of advancing by confirming the radioscopy image, helps to shorten operating time, the raising safety.
The height of protuberance 17 is not particularly limited, and is preferably about 1 μ m~0.4mm, more preferably about 5~50 μ m.If the not enough above-mentioned lower limit of the height of protuberance 17 then owing to the reasons such as constituent material of the 1st core the 2, the 2nd core 3, possibly can't give full play to that the effect that protuberance 17 produces being set.On the other hand, if the height of protuberance 17 surpasses above-mentioned higher limit, then, therefore compare with the height of protuberance 17 owing to lumen (lumen) internal diameter that inserts in the foley's tube is determined, have to dwindle the external diameter of the 2nd core 3 of base end side, can't give full play to the rerum natura of the 2nd core 3 sometimes.
This protuberance 17 for example can followingly form.The 1st core 2 and the 2nd core 3 for example can adopt butt welding machine, and the limit applies the voltage of regulation, and the limit makes the cardinal extremity of the 1st core 2 and the front end of the 2nd core 3 add press contacts.By adding press contacts, form melting layer in contact portion, will form junction surface 14 behind this melting layer cooling curing, thereby the 1st core 2 and the 2nd core 3 brute forces are bonded into one.When welding, (for example, in the scope about the 0.1~5mm of 14 front and back, junction surface) forms external diameter and becomes big bump in the regulation zone that comprises junction surface 14.Suitably remove (pruning) this bump, carry out shape adjustments, form protuberance 17 thus.The outer peripheral face of protuberance 17 can be formed level and smooth in fact surface.(shaping) method of removing that need to prove this bump for example can enumerate grind cut, chemical treatment method such as grinding, etching.
Core body 10 has following mechanical property.Tensile load-extensograph (ideograph) when Fig. 4 and Fig. 5 are respectively the core body carried out tension test.Below, with reference to Fig. 4 and Fig. 5, describe the present invention in detail.
The specific length that core body 10 is comprised junction surface 14 (for example, with junction surface 14 is the center, when tension test is carried out at the position length about the 20~60mm of front and back), as shown in Figure 4, in tensile load-extensograph, have to the upper right side Hookean region A of linearly extension roughly, the yield range B of the approximate horizontal that links to each other with this Hookean region A (or extend to upper right side), with link to each other with this yield range B to the upper right side linearity region C of linearly extension roughly, (far above the load of yield range B terminal) ruptures near the terminal of linearity region C.And the fracture position of core body 10 is the position beyond 14 at the junction surface, promptly in the stage casing of the 1st core 2 or the stage casing of the 2nd core 3.
After beginning to stretch, in tensile load-extensograph, at first, the roughly Hookean region A of linearly extension appears.Behind Hookean region A, further increase load, the yield range B that slope is lower than this Hookean region A then appears.
Because the 1st core 2 is made of the material that elastic modelling quantity is lower than the 2nd core 3, therefore can think that Hookean region A reflects the physical characteristic of the 1st core 2 constituent materials more.If 2 load-extension curve as approximate horizontal of the 1st core, then yield range B is roughly linearly and the line of level (smooth) (referring to Fig. 4).In the terminal (right-hand member among Fig. 4) of yield range B, do not rupture in junction surface 14 yet.That is, all do not rupture near constituting near the boundary portion of layer itself (inside of layer), this layer at junction surface 14 and this layer and the 2nd core 3 with the boundary portion of the 1st core 2.
Next for surpass yield range B, to the upper right side linearity region C of linearly extension roughly.Can think that this linearity region C reflects the stack of the two physical characteristic of constituent material of the constituent material of the 1st core 2 and the 2nd core 3.Junction surface 14 has the fracture strength above yield range B, thereby make the 1st core 2 to the 2 cores 3 more be rich in flexibility, even near junction surface 14 for example, near the yield range B terminal power is powerful to stretch or crooked or reverse to be equivalent to, and also can keep the engagement state at junction surface 14.Therefore, leading line 1 can obtain higher reliability and safety.
If further increase load, then finally in the C of linearity region, rupture, in tensile load-extensograph, show as the vertical line that descends from breakaway poing D.The terminal of linearity region C is breakaway poing D, still, if amplify near it, then except tensile load-extension curve is pointed shape, the phenomenon (amplify among Fig. 4 and show) that tensile load-extension curve has crooked bending section E downwards can also occur.
This bending section E is closing on when fracture, for example forms because of the leading section generation necking down of the 2nd core 3 (narrowing down in the middle part of causing because of external diameter reduces: be also referred to as necking down).The degree of necking down is more little, and the radius of curvature of bending section E is more little, more near pointed shape.Necking occurs and represent that the core material has viscosity,, also can not rupture suddenly even make the excessive stress of core load.
The fracture position of core body 10 is most for the position of necking down takes place, but, the leading section of the 2nd core 3 position of necking down (take place) fracture is meant that the arbitrary part in the boundary portion of the boundary portion of the layer itself (layer is inner) that constitutes junction surface 14, this layer and the 1st core 2 and this layer and the 2nd core 3 does not all rupture, and junction surface 14 demonstrates the fracture strength of the leading section that is higher than the 2nd core 3.Its result can obtain higher reliability and safety for leading line 1.
The fracture strength of core body 10 is not particularly limited, and is preferably 4kg weight or more than the 4kg weight, and 5kg weight or more than the 5kg weight more preferably most preferably is 8kg weight or more than the 8kg weight.
Fig. 5 (a) and Fig. 5 (b) illustrate other patterns of tensile load-extensograph.The Hookean region A of tensile load-extension curve and yield range B and Fig. 4 are roughly the same shown in Fig. 5 (a), and still, the slope of linearity region C is greater than curve shown in Figure 4 (raising rapidly).For example, has above-mentioned tendency as the constituent material of the 2nd core 3 or when increasing the external diameter of the 2nd core 3 at the material that uses elastic modelling quantity big (rigidity height).
The Hookean region A of the tensile load-extension curve shown in Fig. 5 (b) and linearity region C and Fig. 4 are roughly the same, and yield range B is to the roughly linearly extension in upper right side.At this moment, the slope of yield range B is less than the slope of Hookean region A, in addition, and also less than the slope of linearity region C.For example, can access this curve when constituting the 1st core 2 itself, can think that this material is the material with the tensile load-extension curve (stress-deformation curve) of also extending to the upper right side later in yield point with the material that shows pseudoelasticity.In addition, can enumerate the 1st core 2 is formed on cone-shaped that near junction surface 14 outer radial front ends reduce gradually,, this cone-shaped part be applied load to surpass the load of Hookean region A.In addition, even the material of the 1st core 2 itself has smooth yielding curve, the core shape also can influence tensile load-extension curve, thereby makes yield range B have slope.
During the draw speed when core body 10 is carried out tension test slow (for example for about the 0.5mm/ branch), the tendency that the yield range B of tensile load-extension curve has level or extends to the upper right side with less slope; During draw speed very fast (for example for about the 5mm/ branch), the yield range B of tensile load-extension curve has the tendency of extending to the upper right side with bigger slope.
Below, specific embodiments of the invention are described.
The tension test at the position that comprises junction surface 14 of core body 10 of the present invention is following to be carried out.After adopting upset welding method welding external diameter to be the Ni-Ti alloy wire (the 1st core 2) of 0.335mm and stainless steel wire (SUS302) (the 2nd core 3) that external diameter is 0.335mm, adopt the mechanical grinding method excision to be formed on the protrusion (burr) at junction surface, make it have external diameter in fact uniformly.The test film of making thus is fixed on the chuck of cupping machine, makes the Ni-Ti alloy wire be positioned at the top, stainless steel wire is positioned at the below, and the junction is in central authorities.The chuck spacing is 40mm, and the length of Ni-Ti alloy wire and stainless steel wire is respectively about 20mm.Draw speed is the 0.5mm/ branch.The tension test sheet is to rupturing under these conditions.Its tensile load-extension curve is illustrated in Fig. 6.
In Fig. 6,, then occur to the upper right side Hookean region of linearly extension roughly if as described above the position that comprises above-mentioned junction surface 14 is applied load.If further apply load, then surpassing under the load of 4kg weight, demonstrate the yield range of approximate horizontal.Occur the linearity region of extending after this, be 6% at percentage elongation, near generation necking down load surpasses 8kg weight, rupture subsequently to the upper right side.In the test film of reality, do not rupture in junction surface 14, but rupture in the part near junction surface 14 of stainless steel wire.This result is presented in the leading line of the present invention, and the fracture strength at junction surface 14 is greater than the leading section of the 2nd core 3.
Need to prove that Fig. 4 and Fig. 5 show the ideograph of tensile load-extension curve, the present invention comprises that also straight line portion has some bendings or broken line partly has the situation of radian.In addition, in the present invention, tensile load-extension curve is not limited to the pattern shown in each figure.
As shown in Figure 1, core body 10 has the coating 5 (among Fig. 2 with its omission) of its outer peripheral face of all or part of lining (outer surface).This coating 5 forms for all purposes, and one of them example improves sliding for reducing the friction (resistance to sliding) of leading line 1, thereby improves the operability of leading line 1.
In addition, coating 5 periphery at junction surface 14 of preferably being arranged to be covered at least.As mentioned above,,, can offset or relax this external diameter and change, make near the external diameter of the leading line 1 in junction surface 14 roughly even therefore by being covered with coating 5 because the external diameter of core body 10 changes near junction surface 14 (gradient).Its result is for can improve the move operation of leading line 1 at long axis direction.
To achieve these goals, preferably constitute coating 5 with the material that can reduce friction.Thus, can reduce leading line 1 and can with the frictional resistance (resistance to sliding) of its pipe inner wall that together uses, improve sliding, make the operability of leading line 1 in conduit become more good.In addition, by reducing the resistance to sliding of leading line 1, leading line 1 is moved and/or during rotation in conduit, can prevent more positively that leading line 1 from kinking (warpage) taking place or reverse, preventing that particularly it from kinking taking place or reverse near junction surface 14.
Material as the above-mentioned resistance of can reducing friction, for example can enumerate polyolefin such as polyethylene, polypropylene, the composite of polrvinyl chloride, polyester (PET, PBT etc.), polyamide, polyimides, polyurethane, polystyrene, Merlon, organic siliconresin, fluorine resin (PTFE, ETFE etc.) or above-mentioned material.
Wherein, particularly under the situation of using the fluorine resin composite of this resin (or contain), can more effectively reduce the frictional resistance (resistance to sliding) of leading line 1 and pipe inner wall, improve sliding, make the operability of leading line 1 in conduit become more good.In addition, thus, leading line 1 is moved and/or during rotation in conduit, can prevent more positively that leading line 1 from kinking (warpage) taking place or reverse, particularly prevent that it from kinking taking place or reverse near weld part.
In addition, under the situation of using the fluorine resin composite of this resin (or contain), adopt usually freeze, method such as spraying plating, under the state of heating resin material, it is overlayed on the core body 10.Thereby, make the core body 10 and the adaptation of coating 5 become good especially.
In addition, if constitute coating 5 with the organic siliconresin composite of organic siliconresin (or comprise), then when forming coating 5 (on core body 10, being covered),, also can form the coating 5 of certain and powerful driving fit on core body 10 even do not heat.That is, when constituting coating 5,, therefore can at room temperature form coating 5 owing to can use reaction-curable material etc. with the organic siliconresin composite of organic siliconresin (or comprise).Thus,, can be covered simply, can under the state of the bond strength of fully keeping weld part 14 places the 1st core 2 and the 2nd core 3, operate leading line simultaneously by at room temperature forming coating 5.
In addition, as other preferences of the material that can reduce friction, can enumerate hydrophilic material or hydrophobic material.Wherein, special preferred hydrophilic material.
As hydrophilic material, (for example for example can enumerate cellulose family macromolecule material, polyoxyethylene polymer substance, maleic anhydride family macromolecule material, methyl vinyl ether-maleic acid copolymer and so on copolymer-maleic anhydride), acrylic amide polymer substance (for example, the block copolymer of polyacrylamide, polymethylacrylic acid glycidyl esters-DMAA (PGMA-DMAA)), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone etc.
Under the more situation of above-mentioned hydrophilic material, by moistening (moisture absorption) effect, the performance lubricity, reduce leading line 1 and can with the frictional resistance (resistance to sliding) of its pipe inner wall that together uses.Thereby improve the sliding of leading line 1, make the operability of leading line 1 in conduit become more good.
In addition, also can coating 5 be set for the purpose that improves the safety when inserting leading line 1 in the blood vessel.In order to realize this purpose, preferably constitute coating 5 with the material (soft material) that is rich in flexibility.
As the material that is rich in flexibility, for example can enumerate polyolefin such as polyethylene, polypropylene, the composite of forming more than 2 kinds or 2 kinds in various elastomeric materials such as thermoplastic elastomer (TPE), latex rubber, organic silicon rubbers such as polrvinyl chloride, polyester (PET, PBT etc.), polyamide, polyimides, polyurethane, polystyrene, organic siliconresin, polyurethane elastomer, polyester elastomer, polyamide elastomer or the above-mentioned material.
Particularly constitute under the situation of coating 5 with thermoplastic elastomer (TPE) such as polyurethane elastomer or various elastomeric material, owing to further improved the flexibility of leading line 1 leading section, therefore in the time of in inserting blood vessel, can more positively prevent the damage to blood vessel etc., safety is very high.
This coating 5 also can be the laminated body more than 2 layers or 2 layers, and for example, according to the formation position difference of core body 10, the material composition that constitutes coating 5 also can be different.For example, in the part at lining junction surface 14 and the part beyond this part, the constituent material of coating 5 also can be different.In addition, can by the above-mentioned material that is rich in flexibility constitute leading line 1 leading section (for example than external diameter decrescence portion 16 more near the position of front), to improve its safety, constitute position in addition, this position with the above-mentioned material that can reduce friction simultaneously, to improve operability.
The thickness of coating 5 is not particularly limited, and considers that formation purpose or constituent material, the formation method etc. of coating 5 are suitably selected, and thickness (on average) is preferably about 1~30 μ m usually.More preferably about 2~15 μ m.If the thickness of coating 5 is thin excessively, then can't give full play to the purpose that forms coating 5, in addition, coating 5 may be peeled off; If the thickness of coating 5 is blocked up, then may influence the physical characteristic of core body 10, in addition, coating 5 may be peeled off.
Need to prove in the present invention, also can implement to be used to improve processing (chemical treatment, heat treatment etc.) with the adaptation of coating 5, or the intermediate layer that can improve with the adaptation of coating 5 is set at the outer peripheral face (surface) of core body 10.
User mode when Fig. 7 and Fig. 8 illustrate respectively leading line 1 of the present invention is used for PTCA.
Among Fig. 7 and Fig. 8, label 40 expression large artery trunks bows, the right coronary artery of label 50 expression hearts, label 60 expression right coronary artery peristomes, label 70 expression angiostenosis portions (diseased region).In addition, label 30 positively imports the guiding catheter of right coronary artery with leading line 1 from the thigh tremulous pulse for being used for, and label 20 is the narrow expansion foley's tube of the sacculus 201 that has expansion at fore-end and shrink freely.Following operating under the radioscopy carried out.
As shown in Figure 7, make the front end of leading line 1 outstanding, insert in the right coronary artery 50 from right coronary artery peristome 60 from the front end of guiding catheter 30.Then, push ahead leading line 1, begin to insert in the right coronary artery 50, front end is stopped at cross the position of angiostenosis portion 70 from front end.Guarantee the path of foley's tube 20 thus.Need to prove that the junction surface 14 of leading line 1 this moment is positioned at the descending large artery trunks side (body) of large artery trunks bow 40.
Then, as shown in Figure 8, make the front end of the foley's tube 20 that inserts from the base end side of leading line 1 outstanding from the front end of guiding catheter 30, push ahead along leading line 1 again, insert in the right coronary artery 50 from right coronary artery peristome 60, when sacculus 20 arrives the position of angiostenosis portion 70, stop to move.
Next, the base end side injection balloon expandable fluid from foley's tube 20 makes sacculus 201 expansions, thus blood vessel dilating narrow 70.Thus, the deposits such as cholesterol on the blood vessel that is deposited in angiostenosis portion 70 are adhered in the physical property expansion, hinder thereby can eliminate blood flow.
More than, based on illustrated embodiment leading line of the present invention has been described, still, the present invention is not limited thereto, and the various piece that constitutes leading line can replace to the parts of any formation that can bring into play said function.In addition, also can increase arbitrary structures.
In addition, the purposes of leading line of the present invention also is not limited to above-mentioned PTCA.
More than just the present invention be illustrated as the purposes of leading line, still, foregoing invention also goes for the purposes beyond the leading line.For example, also can be used to have disposed the intervention devices such as conduit of the parts that front parts and base end side parts are welded.

Claims (19)

1, a kind of leading line, this leading line has the core body, described core body is by the 1st core that is configured in front, with the cardinal extremity that is bonded on described the 1st core, constitute greater than the 2nd core that the material of the constituent material of described the 1st core constitutes by elastic modelling quantity, it is characterized by, the junction surface of described the 1st core and described the 2nd core forms the curved surface shape, and is with respect to the roughly symmetric shape of the central shaft of described core body.
2, leading line as claimed in claim 1 is characterized by, and described junction surface forms the convex-shaped to the proximal direction projection of described core body.
3, leading line as claimed in claim 1 is characterized by, and described junction surface forms the convex-shaped to the preceding extreme direction projection of described core body.
4, leading line as claimed in claim 1 is characterized by, and adopts welding method to engage described the 1st core and described the 2nd core.
5, leading line as claimed in claim 1 is characterized by, and described junction surface forms layer structure.
6, leading line as claimed in claim 5 is characterized by, and the junction surface thickness of described formation layer structure is 0.001~100 μ m.
7, leading line as claimed in claim 1 is characterized by, and the external diameter that described core body is located at described junction surface is greater than the external diameter at the base end side position at described junction surface.
8, a kind of leading line, this leading line has the core body, described core body is via wire 1st core of junction surface engagement arrangement in front, the 2nd core that constitutes with the base end side that is configured in described the 1st core, by the material that is different from described the 1st core and constituting, it is characterized by, at described junction surface, at least one composition in the constituent material of described the 1st core reduces to proximal direction, and at least one composition forward end direction in the constituent material of described the 2nd core reduces.
9, leading line as claimed in claim 8 is characterized by, and described the 2nd core is made of the material of elastic modelling quantity greater than the constituent material of described the 1st core.
10, leading line as claimed in claim 8 is characterized by, and described the 1st core and described the 2nd core material separately contain common metallic element.
11, leading line as claimed in claim 8 is characterized by, and described the 1st core is made of Ni-Ti class alloy.
12, leading line as claimed in claim 8 is characterized by, and described the 2nd core is made of rustless steel or Co base alloy.
13, leading line as claimed in claim 8 is characterized by, and described junction surface forms the curved surface shape.
14, a kind of leading line, this leading line has the core body, this core body has the front of being configured in, the 1st core that constitutes by the material that shows pseudoelasticity, with through the cardinal extremity of solder joints at described the 1st core, the 2nd core that constitutes greater than the material of the constituent material of described the 1st core by elastic modelling quantity, it is characterized by, in the tensile load-extensograph at the position that comprises the junction surface of described core body, has Hookean region to the linearly extension in upper right side, the approximate horizontal that links to each other with this Hookean region or the yield range that extends to the upper right side, have from described yield range terminal and begin the characteristic that under higher load, ruptures, and this fracture position is the position beyond the described junction surface.
15, a kind of leading line, this leading line has the core body, this core body has the front of being configured in, the 1st core that constitutes by the material that shows pseudoelasticity, with through the cardinal extremity of solder joints at described the 1st core, the 2nd core that constitutes greater than the material of the constituent material of described the 1st core by elastic modelling quantity, it is characterized by, when tension test is carried out at the position that comprises the junction surface of described core body, in tensile load-extensograph, have to the upper right side Hookean region of linearly extension roughly, the approximate horizontal that links to each other with this Hookean region or the yield range that extends to the upper right side, with link to each other with this yield range to the linearity region of linearly extension roughly, upper right side, have near the characteristic that the terminal of described linearity region, ruptures, and the fracture strength at described junction surface is higher than the leading section of described the 2nd core.
16, as claim 14 or 15 described leading lines, it is characterized by, in described tensile load-extensograph, when closing on fracture, occur the crooked phenomenon of tensile load-extension curve that causes by the necking down effect downwards.
17, as claim 14 or 15 described leading lines, it is characterized by, the fracture strength of described core body is a 4kg weight or more than the 4kg weight.
18, as claim 14 or 15 described leading lines, it is characterized by, described the 1st core is made of superelastic alloy.
19, as claim 14 or 15 described leading lines, it is characterized by, described the 2nd core is made of rustless steel or Co base alloy.
CNB2004100903851A 2003-12-18 2004-11-12 Leading line Active CN100558423C (en)

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US20120310218A1 (en) 2012-12-06
US8313445B2 (en) 2012-11-20
ATE422931T1 (en) 2009-03-15
EP1832308B1 (en) 2009-02-18
DE602004019589D1 (en) 2009-04-02
KR101153506B1 (en) 2012-06-11
US20100286663A1 (en) 2010-11-11
KR20050062404A (en) 2005-06-23
KR20130009710A (en) 2013-01-23
KR20110074727A (en) 2011-07-01
US9033004B2 (en) 2015-05-19
EP1543857B1 (en) 2007-08-08
US20050152731A1 (en) 2005-07-14
DE602004008019T2 (en) 2008-04-24
ATE369176T1 (en) 2007-08-15
KR101329394B1 (en) 2013-11-14
EP1832308A1 (en) 2007-09-12
DE602004008019D1 (en) 2007-09-20
KR101180518B1 (en) 2012-09-06
CN100558423C (en) 2009-11-11
EP1543857A1 (en) 2005-06-22
US7785274B2 (en) 2010-08-31
US20120228273A1 (en) 2012-09-13
KR20120039566A (en) 2012-04-25
KR101326997B1 (en) 2013-11-14

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